4.10.1 The Submitter should seek approval of the
Preliminary design from the Administration. The purpose of this is
to verify that the alternative and/or equivalency is feasible and
sound. The preliminary approval may therefore not be granted until
all hazards and failure modes related to the design are identified
and until control options (or plans for how to achieve control) of
these hazards and failure modes are described. The following conditions
should be satisfied prior to granting preliminary approval:
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.1 no "showstoppers" were identified, otherwise
a re-evaluation of the Preliminary Design phase and possibly improvements
should be carried out; and
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.2 the alternative and/or equivalency was found
feasible and suitable for its expected application.
4.10.2 Such a preliminary approval may be useful
with respect to project partners, financial institutions and additional
regulatory agencies. The preliminary approval may also assist the
Submitter in staying focused on the most important issues.
4.10.3 It should be noted that the issue of a
preliminary approval statement by the Administration does not imply
that final approval will be granted. However, at this stage, the underlying
analyses (e.g. the risk analysis) may define the basis for design,
sometimes referred to as the design basis or the design specification.
A preliminary approval statement can facilitate the formal clarification
of these aspects.
4.10.4 The basis for preliminary approval may
consist of:
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.1 a description of the alternative and/or equivalency,
its specifications, its functional requirements, its operation and
maintenance, health, safety and environmental issues, its interface
with other systems, etc.;
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.2 preliminary drawings;
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.3 specifications of codes and standards applied
(including specification of the applicable classification rules or
part of rules);
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.4 specification of the applicable administration
requirements;
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.5 hazard identification results;
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.6 risk assessment plans or results of risk assessment
for preliminary design, including evaluation method, evaluation metrics
and evaluation criteria;
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.7 design casualty scenarios;
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.8 testing and analyses plans;
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.9 special requirements for the project; and
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.10 description of the approval process.
4.10.5 The preliminary approval should be issued
with a set of conditions outlining the requirements and necessary
steps the Submitter needs to satisfy and a list of documents that
will be required in order to achieve final approval.